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510(k) Data Aggregation

    K Number
    K973415
    Device Name
    CURVILINEAR SUTURE PLACEMENT SYSTEM
    Manufacturer
    LAURUS MEDICAL CORP.
    Date Cleared
    1997-12-02

    (84 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Laurus Medical Curvilinear Suture Placement System is indicated for the placement of suture in a variety of Transvaginal procedures such as prolapse repair, cystourethropexy, and bladder neck stabilization; through Cooper's Ligament alone and/or in conjunction with non-device suturing procedures for the correction of urinary stress incontinence: for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

    Device Description

    Curvilinear Suture Placement Device

    AI/ML Overview

    I am sorry, but the provided text does not contain the information you requested about acceptance criteria and study details for the Curvilinear Suture Placement Device. The document is a 1997 FDA 510(k) clearance letter confirming that the device is substantially equivalent to previously marketed devices. It primarily focuses on regulatory approval and does not include details about device performance studies, acceptance criteria, sample sizes, or ground truth establishment.

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